Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy

NCT ID: NCT06189781

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-06-30

Brief Summary

Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression.

Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.

Detailed Description

Over the past decade, there has been an ongoing shift away from the use of opioids in the postoperative setting due to both their negative side effects and their high potential for dependence and abuse. Various new techniques for multimodal pain management are increasingly being utilized in adult orthopaedics, including injection of local anesthetics and analgesic agents. These techniques aim to block pain directly at the site of injection in order to reduce postoperative pain while minimizing systemic effects and preserving motor function, allowing for early mobilization. Numerous randomized controlled trials in both the arthroplasty and adult trauma populations have demonstrated reduced pain and narcotic consumption with local analgesia injection, but there is scant evidence on the efficacy of similar injections in pediatric surgical patients. While robust evidence demonstrating both safety and efficacy of these injections has led to routine use in the adult orthopaedic population, use in pediatric patients still remains limited, likely due to a lack of level I therapeutic evidence.

Local anesthetic injections offer several theoretical advantages over current pain management modalities. When compared with other methods of anesthesia, including epidural anesthesia or some peripheral nerve blocks, local anesthetic injections preserve motor function, allowing for early mobilization and rehabilitation. Additionally, they do not require specialized equipment or anesthesia personnel and can be administered in the operating room without significantly affecting the duration of the procedure. While a mainstay in traditional pain management protocols, epidural anesthesia in the pediatric CP population poses specific risks including damage to preexisting intrathecal baclofen pumps and iatrogenic infection. Moreover, epidural insertion can be a technically demanding procedure in these patients given high rates of concomitant neuromuscular scoliosis. Prior retrospective studies comparing peripheral nerve and lumbar plexus blocks compared to epidural anesthesia have shown mixed results in decreasing pain scores and opioid use in this patient population. As described in Preliminary Data section below, the investigators' pilot randomized control trial demonstrated significantly decreased pain scores and narcotic use postoperatively in pediatric patients with CP who received multimodal analgesia injection compared to placebo while undergoing hip surgery. The present study aims to substantively contribute to current literature by providing level I evidence comparing the safety and efficacy of surgical site injections with epidural anesthesia in a patient population for whom pain management remains challenging.

Conditions

Cerebral Palsy; Hip Dysplasia; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pain Injection

The local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac.

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

The local anesthetic group will be injected with ropivacaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), and ketorolac 30mg/mL (0.5mg/kg). The maximum dose of ropivacaine regardless of patient weight will be 200mg. This is based on recommended maximum dose protocols from our anesthesia colleagues. If bilateral hips are involved, the total amount will be split evenly between the two sides.

Epidural

The control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively.

Group Type: ACTIVE_COMPARATOR

Bupivacaine, lidocaine, ropivacaine

Intervention Type: DRUG

The lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team.

Interventions

Ropivacaine injection

The local anesthetic group will be injected with ropivacaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), and ketorolac 30mg/mL (0.5mg/kg). The maximum dose of ropivacaine regardless of patient weight will be 200mg. This is based on recommended maximum dose protocols from our anesthesia colleagues. If bilateral hips are involved, the total amount will be split evenly between the two sides.

Intervention Type: DRUG

Bupivacaine, lidocaine, ropivacaine

The lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• under 18 years old
• diagnosis of cerebral palsy or similar neuromuscular disease
• undergoing uni- or bilateral proximal femoral osteotomy

Exclusion Criteria

• ongoing preoperative opioid use
• history of allergic reaction to any component of the pain injection
• history of adverse reaction to epidural anesthesia

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Rachel Thompson, MD

Director, Center for Cerebral Palsy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel M Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Orthopaedic Institute for Children

Los Angeles, California, United States

Site Status: RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

UCLA Medical Center, Santa Monica

Santa Monica, California, United States

Site Status: RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Rachel M Thompson, MD

Role: CONTACT

rathompson@mednet.ucla.edu

213-742-1369

Nicole J Hung, MD

Role: CONTACT

nhung@mednet.ucla.edu

310-592-5180

Facility Contacts

Nicole J Hung, MD

Role: primary

310-592-5180

Nicole J Hung, MD

Role: primary

nhung@mednet.ucla.edu

310-592-5180

Nicole J Hung, MD

Role: primary

310-592-5180

Elizabeth Klein

Role: primary

eklein@luriechildrens.org

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Other Identifiers

IRB#23-000902

Identifier Type: -

Identifier Source: org_study_id